FDA.report

De Soutter Medical

Primary DI
05051471010741
Brand
De Soutter Medical
Company
DE SOUTTER MEDICAL LIMITED
Model
3940
Catalog number
3940
Device description
STEM CUTTER-38mm DIA DIAMOND DISC AND ARBOR ASSEMBLY
Published
2022-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GEYMotor, Surgical Instrument, Ac-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05051471010741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05051471010741050514710107415051471010741

GMDN Terms

TermDefinition
Metal-cutting burA rotary cutting device consisting of a shaft and a cutting working end made of hard materials (e.g., high-grade steel, carbide, diamond) which is designed to fit into an appropriate powered handpiece that provides the rotation, and is intended for cutting hard metal, typically a device/implant during orthopaedic surgery. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
458064144
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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05051471220195De Soutter Medical21630216302026-03-24
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05051471214453De Soutter Medical21440214402025-09-17
05051471214460De Soutter Medical21450214502025-09-17
05051471214477De Soutter Medical21460214602025-09-17
05051471214484De Soutter Medical21470214702025-09-17
05051471214491De Soutter Medical21480214802025-09-17
05051471214507De Soutter Medical21490214902025-09-17
15051471214788De Soutter MedicalT20-110T20-1102025-09-12
15051471214795De Soutter MedicalT20-173T20-1732025-09-12
15051471217123De Soutter MedicalT20-171T20-1712025-09-12
15051471217130De Soutter MedicalT20-172T20-1722025-09-12
05051471217140De Soutter Medical21520215202025-09-12

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Primary DIBrandCompanyProduct codePublished
05051471220195De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-03-24
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05051471220812De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-03-02
05051471220836De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-03-02
05051471220263De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-01-29
00193982678906VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
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00193982679002VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679286VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
05051471219625De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-01-05
04055207036693POWER STICK M5/0Richard Wolf GmbHGEY2025-12-18
05051471215283De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-12-04
05051471219038De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-12-04
05051471219175De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-12-04
05051471219199De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-12-04
05051471214453De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-09-17
05051471214460De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-09-17
05051471214477De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-09-17
05051471214484De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-09-17
05051471214491De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-09-17